Last reviewed 2026-05-15 · How we verify

BIKTARVY Tablets (BIK)

ViiV Healthcare · Phase 3 active Small molecule

BIKTARVY Tablets (BIK) is a Antiretroviral combination therapy (INSTI + NRTI + NRTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing).

BIKTARVY is a fixed-dose combination of three antiretroviral agents that inhibit HIV replication through complementary mechanisms: reverse transcriptase inhibition, integrase inhibition, and protease inhibition. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing).

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BIKTARVY Tablets (BIK)
Sponsor	ViiV Healthcare
Drug class	Antiretroviral combination therapy (INSTI + NRTI + NRTI)
Target	HIV reverse transcriptase, HIV integrase, HIV protease
Modality	Small molecule
Therapeutic area	Infectious Disease / Virology
Phase	Phase 3

Mechanism of action

BIKTARVY combines bictegravir (an integrase strand transfer inhibitor), tenofovir alafenamide (a nucleotide reverse transcriptase inhibitor), and emtricitabine (a nucleoside reverse transcriptase inhibitor). Together, these agents target multiple steps of the HIV replication cycle, preventing viral DNA synthesis and integration into the host genome, thereby suppressing viral load and preserving immune function.

Approved indications

HIV-1 infection in treatment-naïve and treatment-experienced adults
HIV-1 infection in adolescents and children (weight-based dosing)

Common side effects

Diarrhea
Nausea
Headache
Fatigue
Abdominal pain
Rash

Key clinical trials

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BIKTARVY Tablets (BIK) CI brief — competitive landscape report
BIKTARVY Tablets (BIK) updates RSS · CI watch RSS
ViiV Healthcare portfolio CI

Frequently asked questions about BIKTARVY Tablets (BIK)

What is BIKTARVY Tablets (BIK)?

BIKTARVY Tablets (BIK) is a Antiretroviral combination therapy (INSTI + NRTI + NRTI) drug developed by ViiV Healthcare, indicated for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing).

How does BIKTARVY Tablets (BIK) work?

What is BIKTARVY Tablets (BIK) used for?

BIKTARVY Tablets (BIK) is indicated for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing).

Who makes BIKTARVY Tablets (BIK)?

BIKTARVY Tablets (BIK) is developed by ViiV Healthcare (see full ViiV Healthcare pipeline at /company/viiv-healthcare).

What drug class is BIKTARVY Tablets (BIK) in?

BIKTARVY Tablets (BIK) belongs to the Antiretroviral combination therapy (INSTI + NRTI + NRTI) class. See all Antiretroviral combination therapy (INSTI + NRTI + NRTI) drugs at /class/antiretroviral-combination-therapy-insti-nrti-nrti.

What development phase is BIKTARVY Tablets (BIK) in?

BIKTARVY Tablets (BIK) is in Phase 3.

What are the side effects of BIKTARVY Tablets (BIK)?

Common side effects of BIKTARVY Tablets (BIK) include Diarrhea, Nausea, Headache, Fatigue, Abdominal pain, Rash.

What does BIKTARVY Tablets (BIK) target?

BIKTARVY Tablets (BIK) targets HIV reverse transcriptase, HIV integrase, HIV protease and is a Antiretroviral combination therapy (INSTI + NRTI + NRTI).

Drug class: All Antiretroviral combination therapy (INSTI + NRTI + NRTI) drugs
Target: All drugs targeting HIV reverse transcriptase, HIV integrase, HIV protease
Manufacturer: ViiV Healthcare — full pipeline
Therapeutic area: All drugs in Infectious Disease / Virology
Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced adults
Indication: Drugs for HIV-1 infection in adolescents and children (weight-based dosing)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing